LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES— 510(k) K053227

Name: FDA 510(k) clearance K053227
Creator: U.S. Food and Drug Administration
Published: 2006-01-13

Substantially Equivalent

Medical Illumination International, Inc.

FDA 510(k) clearance K053227 for LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES, Substantially Equivalent on 2006-01-13. Applicant: Medical Illumination International, Inc.. Device class: 2.

Clearance details

Applicant: Medical Illumination International, Inc.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2005-11-17
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

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